# K243253: 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Jun 18, 2025 after 246 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K935595 (1995). 336 ancestors in all.
2 later devices descend from it; 2 cite it directly.
7 of 339 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230179: 6440 MyLabX90, Esaote, S.p.A. (2023) Summary page 5.

## Most influential descendants
- K253288: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (2026), 0 descendants of its own
- K253310: 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) (2025), 0 descendants of its own

## Indications for use
The multifunctional ultrasound scanner is used to collect, display and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes. Main application: - Cardiac Districts: Cardiac Adult, Cardiac Pediatric Invasive access: Transesophageal - Vascular Districts: Neonatal, Adult Cephalic, Vascular Invasive access: Not applicable - General Imaging Districts: Abdominal, Breast, Musculoskeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological Invasive access: Intraoperative (Abdominal), Laparoscopic, Transrectal - Women Health Districts: OB/Fetal, Gynecology Invasive access: Transrectal, Transvaginal The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both Pulsed Wave (PW) and Continuous Wave (CW)), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes, Elastosonography, 3D/4D and CnTI. The ultrasound scanner is suitable to be installed in professional healthcare facility environment and is designed for ultrasound practitioners.

Source page: https://510kreport.com/device/K243253
Methodology: https://510kreport.com/methodology